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Design and methods of the Population Assessment of Tobacco and Health (PATH) Study
  1. Andrew Hyland1,
  2. Bridget K Ambrose2,
  3. Kevin P Conway3,
  4. Nicolette Borek2,
  5. Elizabeth Lambert3,
  6. Charles Carusi4,
  7. Kristie Taylor4,
  8. Scott Crosse4,
  9. Geoffrey T Fong5,6,
  10. K Michael Cummings7,
  11. David Abrams8,
  12. John P Pierce9,
  13. James Sargent10,
  14. Karen Messer9,
  15. Maansi Bansal-Travers1,
  16. Ray Niaura8,
  17. Donna Vallone8,
  18. David Hammond6,
  19. Nahla Hilmi3,
  20. Jonathan Kwan2,
  21. Andrea Piesse4,
  22. Graham Kalton4,
  23. Sharon Lohr4,
  24. Nick Pharris-Ciurej2,
  25. Victoria Castleman4,
  26. Victoria R Green3,13,
  27. Greta Tessman2,
  28. Annette Kaufman11,
  29. Charles Lawrence4,
  30. Dana M van Bemmel2,
  31. Heather L Kimmel3,
  32. Ben Blount12,
  33. Ling Yang2,
  34. Barbara O'Brien4,
  35. Cindy Tworek2,
  36. Derek Alberding2,
  37. Lynn C Hull2,
  38. Yu-Ching Cheng2,
  39. David Maklan4,
  40. Cathy L Backinger2,
  41. Wilson M Compton3
  1. 1Roswell Park Cancer Institute, Buffalo, New York, USA
  2. 2Center for Tobacco Products, US Food and Drug Administration, Silver Spring, Maryland, USA
  3. 3National Institute on Drug Abuse, National Institutes of Health, US Department of Health and Human Services, Bethesda, Maryland, USA
  4. 4Westat, Rockville, Maryland, USA
  5. 5University of Waterloo, Waterloo, Ontario, USA
  6. 6Ontario Institute for Cancer Research, Toronto, Ontario, USA
  7. 7Medical University of South Carolina, Charleston, South Carolina, USA
  8. 8Schroeder Institute for Tobacco Research and Policy Studies, Truth Initiative, Washington, District of Columbia, USA; The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
  9. 9University of California at San Diego, San Diego, California, USA
  10. 10Dartmouth College, Hanover, New Hampshire, USA
  11. 11National Cancer Institute, National Institutes of Health, US Department of Health and Human Services, Bethesda, Maryland, USA
  12. 12CDC National Center for Environmental Health, US Department of Health and Human Services, Atlanta, Georgia, USA
  13. 13Kelly Government Solutions, Rockville, Maryland, USA
  1. Correspondence to Dr Andrew Hyland, Department of Health Behavior, Roswell Park Cancer Institute, Buffalo, NY 14263, USA; Andrew.Hyland{at}


Background This paper describes the methods and conceptual framework for Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study data collection. The National Institutes of Health, through the National Institute on Drug Abuse, is partnering with the Food and Drug Administration's (FDA) Center for Tobacco Products to conduct the PATH Study under a contract with Westat.

Methods The PATH Study is a nationally representative, longitudinal cohort study of 45 971 adults and youth in the USA, aged 12 years and older. Wave 1 was conducted from 12 September 2013 to 15 December 2014 using Audio Computer-Assisted Self-Interviewing to collect information on tobacco-use patterns, risk perceptions and attitudes towards current and newly emerging tobacco products, tobacco initiation, cessation, relapse behaviours and health outcomes. The PATH Study's design allows for the longitudinal assessment of patterns of use of a spectrum of tobacco products, including initiation, cessation, relapse and transitions between products, as well as factors associated with use patterns. Additionally, the PATH Study collects biospecimens from consenting adults aged 18 years and older and measures biomarkers of exposure and potential harm related to tobacco use.

Conclusions The cumulative, population-based data generated over time by the PATH Study will contribute to the evidence base to inform FDA's regulatory mission under the Family Smoking Prevention and Tobacco Control Act and efforts to reduce the Nation's burden of tobacco-related death and disease.

  • Public policy
  • Prevention
  • Surveillance and monitoring
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